Erlotinib vs. Standard Chemotherapy in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) and Eastern Cooperative Oncology Group (ECOG)Performance Status (PS) 2

Completed · Phase 2

Conditions studied: Non-Small Cell Lung Cancer

In brief

The purpose of this noncomparative study is to obtain preliminary estimates of the efficacy of erlotinib and standard chemotherapy in patients with advanced, previously untreated nonsmall cell lung cancer (NSCLC) and an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 2. The study will also evaluate the safety of single-agent erlotinib in this patient population.

Key facts

Study ID

NCT00085839

Run by

OSI Pharmaceuticals

People needed

103

Starts

2004-02-01

Expected to finish

2007-03-01

Last updated by the study team

2012-08-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Stage IIIB or IV Nonsmall cell lung cancer (NSCLC)
• No prior chemotherapy
• Eastern Cooperative Oncology Group (ECOG) Performance Status 2
• Clinically or radiologically measurable disease per RECIST criteria

You may not qualify if…

• Gastro-intestinal abnormalities
• Any concurrent anticancer therapy
• Prior treatment with epidermal growth factor receptor (EGFR) inhibitors of any kind
• Other active malignancies
• Uncontrolled brain metastases
• Severe abnormalities of the cornea
• Significant cardiac disease

Where it is running

• California Cancer Care, Inc. — Greenbrae, California, United States
• Sharp Clinical Oncology Research — San Diego, California, United States
• Holy Cross Hospital — Fort Lauderdale, Florida, United States
• University of Miami — Miami, Florida, United States
• Mount Sinai Cancer Center — Miami Beach, Florida, United States
• Evanston Northwestern Healthcare — Evanston, Illinois, United States
• Oncology/Hematology Associates of Central Illinois — Peoria, Illinois, United States
• Norton Healthcare, Inc. — Louisville, Kentucky, United States
• Maryland Hematology/Oncology Associates — Baltimore, Maryland, United States
• VA Sierra Nevada Health Care System — Reno, Nevada, United States
• Weill Medical College of Cornell University — New York, New York, United States
• FEK Addo, PC — Bismarck, North Dakota, United States
• Gabrail Cancer Center — Canton, Ohio, United States
• University Hospitals of Cleveland — Cleveland, Ohio, United States
• Ohio State University — Columbus, Ohio, United States
• Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States
• Charleston Hematology Oncology — Charleston, South Carolina, United States
• East Tennessee Oncology/Hematology, PC — Knoxville, Tennessee, United States
• Sarah Cannon Cancer Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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